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Senior Quality Systems Engineer
2 months ago
Senior Quality Systems Engineer
Overview
At J&J Family of Companies, we are seeking a Senior Quality Systems Engineer to become a vital member of our dedicated team. This role is pivotal in ensuring compliance with quality standards and regulations, enhancing our commitment to health and innovation.
About Us
For over a century, our focus on diversity, equity, and inclusion has been integral to our culture and business practices. We strive to create a healthier, more equitable world, where every employee's unique perspective contributes to innovative solutions for pressing healthcare challenges.
Key Responsibilities
The Senior Quality Systems Engineer will be accountable for managing the complete process related to product issue escalations, adhering to quality review frameworks that incorporate global standards and regulations. The role involves:
- Training and mentoring teams in the Product Issue Escalation process to ensure adherence to industry standards.
- Facilitating root cause investigations with cross-functional experts to evaluate regulatory and safety impacts.
- Leading weekly reviews on ongoing investigations, ensuring timely actions and updates are communicated to management.
- Conducting Quality Review Board (QRB) meetings, preparing presentations, and documenting outcomes accurately.
- Collaborating with field action teams to ensure seamless transition of QRB actions.
- Supporting data requests for market surveillance and regulatory compliance.
- Assisting in internal and external audit preparations and activities.
- Managing product issue escalation files and leading resolution efforts.
- Reviewing actions resulting from escalations to ensure alignment with quality standards.
- Communicating effectively across various departments, fostering collaboration and understanding.
Qualifications
Education and Experience
- Bachelor's degree in a scientific or engineering discipline.
- A minimum of 8 years of relevant experience, with at least 5 years in Quality Assurance within regulated industries.
Skills and Competencies
- Proficient in FDA Quality System Regulation and ISO 13485 standards.
- Strong leadership and interpersonal skills, with the ability to guide cross-functional teams.
- Excellent communication skills, capable of conveying complex information to diverse audiences.
- Experience in preparing and reviewing technical documentation for compliance.
- Ability to thrive in a fast-paced environment while maintaining attention to detail.
Join us in our mission to innovate and improve health outcomes globally. We value our employees and offer competitive compensation and benefits to support their well-being and professional growth.
